EP0896821B1 - Neue Inhalationspräparate enthaltend CR 2039 (Andolast) - Google Patents

Neue Inhalationspräparate enthaltend CR 2039 (Andolast) Download PDF

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Publication number
EP0896821B1
EP0896821B1 EP97830417A EP97830417A EP0896821B1 EP 0896821 B1 EP0896821 B1 EP 0896821B1 EP 97830417 A EP97830417 A EP 97830417A EP 97830417 A EP97830417 A EP 97830417A EP 0896821 B1 EP0896821 B1 EP 0896821B1
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical composition
weight
composition according
active ingredient
pharmaceutically
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP97830417A
Other languages
English (en)
French (fr)
Other versions
EP0896821A1 (de
Inventor
Francesco Makovec
Paolo Senin
Lucio Claudio Rovati
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rottapharm SpA
Original Assignee
Rotta Research Laboratorium SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to DE69722610T priority Critical patent/DE69722610T2/de
Priority to PT97830417T priority patent/PT896821E/pt
Priority to ES97830417T priority patent/ES2199336T3/es
Priority to AT97830417T priority patent/ATE241980T1/de
Priority to EP97830417A priority patent/EP0896821B1/de
Application filed by Rotta Research Laboratorium SpA filed Critical Rotta Research Laboratorium SpA
Priority to AU77327/98A priority patent/AU735204B2/en
Priority to CA002244357A priority patent/CA2244357C/en
Priority to US09/129,794 priority patent/US5976576A/en
Priority to JP22273898A priority patent/JP4301598B2/ja
Publication of EP0896821A1 publication Critical patent/EP0896821A1/de
Application granted granted Critical
Publication of EP0896821B1 publication Critical patent/EP0896821B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Otolaryngology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)

Claims (14)

  1. Eine pharmazeutische Zusammensetzung, welche als aktiven Bestandteil N-4-(1Htetrazol-5-yl)phenyl-4-(1H-tetrazol-5-yl)benzamiddinatriumsalz (CR 2039, Andolast) oder ein anderes pharmazeutisch geeignetes Salz hiervon und einen Geschmackstoff sowie wahlweise eine pharmazeutisch geeignete Trägersubstanz und/oder einen pharmazeutisch geeigneten Süßstoff umfasst, wobei die Zusammensetzung zur Verabreichung durch orale Inhalation geeignet ist.
  2. Eine pharmazeutische Zusammensetzung gemäß Patentanspruch 1, in welcher der aktive Bestandteil CR 2039-Dinatriumsalz ist.
  3. Eine pharmazeutische Zusammensetzung gemäß den Patentansprüchen 1 und 2, welche einen Geschmackstorf wie zum Beispiel Menthol oder Pfefferminzöl in einem Gewichtsverhältnis von zwischen 0,5 und 10% (Gewicht/Gewicht) in Bezug auf das CR 2039-Dinatriumsalz enthält.
  4. Eine pharmazeutische Zusammensetzung gemäß einem der vorher genannten Patentansprüche 1-3, welche auch einen Süßstoff, wie zum Beispiel Saccharose, Fruktose, Glukose, Mannitol, Aspartam, Natriumcyclamat, saures Saccharin oder Natriumsaccharin, enthält.
  5. Eine pharmazeutische Zusammensetzung gemäß einem der vorher genannten Patentansprüche 1-3, welche auch einen oder mehrere wasserlösliche, inerte Trägersubstanzen wie etwa Laktose oder Dextrose enthält.
  6. Eine pharmazeutische Zusammensetzung gemäß einem der vorher genannten Patentansprüche 1-3, welche sowohl einen Süßstoff, der zum Beispiel aus den in Patentanspruch 4 angegebenen Stoffen ausgewählt ist, als auch eine inerte, wasserlösliche Trägersubstanz wie zum Beispiel Laktose oder Dextrose, enthält.
  7. Eine pharmazeutische Zusammensetzung gemäß Patentanspruch 4, welche einen Süßstoff wie etwa Natriumsaccharin in einem Gewichtsverhältnis zwischen 1% und 30%, vorzugsweise zwischen 10 und 20 Gewichtsprozent(Gewicht/Gewicht) in Bezug auf das CR 2039-Dinatriumsalz enthält.
  8. Eine pharmazeutische Zusammensetzung gemäß Patentanspruch 5, welche eine inerte, wasserlösliche Trägersubstanz, wie etwa Laktose oder Dextrose, in einem Gewichtsverhältnis zwischen dem 0,4- und 4-fachen des Gewichts des aktiven Bestandteils enthält.
  9. Einen nachfüllbaren Inhalator zur mehrfachen oralen Verabreichung trockener Pulver, die eine pharmazeutische Zusammensetzung gemäß einem der Patentansprüche 1-8 enthalten.
  10. Einen nachfüllbaren Inhalator zur mehrfachen oralen Verabreichung trockener Pulver bestehend aus mikrofeinen Pellets mit einem Durchmesser zwischen 100 und 1000 Mikrometer, die eine pharmazeutische Zusammensetzung gemäß einem der Patentansprüche 1-8 enthalten.
  11. Eine Hartgelatinekapsel enthaltend eine pharmazeutische Zusammensetzung gemäß einem der Patentansprüche 1-8 zum Gebrauch mit einem passenden Gerät zur Verabreichung der trockenen Pulver zur oralen Inhalation.
  12. Ein Verfahren zur Herstellung einer pharmazeutischen Zusammensetzung, die als aktiven Bestandteil N-4-(1H-tetrazol-5-yl)phenyl-4-(1H-tetrazol-5-yl)-Benzamiddinatriumsalz (CR 2039, Andolast) oder ein anderes pharmazeutisch geeignetes Salz hiervon und einen Geschmackstoff umfasst, sowie wahlweise eine pharmazeutisch geeignete, inerte Trägersubstanz oder einen pharmazeutisch geeigneten Süßstoff oder beides enthält, welches in der Zugabe des in einem flüchtigen, nicht-wäßrigen Lösungsmittel gelösten Geschmackstoffes, Mischen der Lösung mit dem aktiven Bestandteil und Eindampfen des restlichen Lösungsmittels mit gängigen Methoden besteht.
  13. Ein Verfahren gemäß Patentanspruch 12, in welchem der aktive Bestandteil zuvor mit Süßstoffen, wie etwa jenen, die in Patentanspruch 4 angegeben werden, sowie mit inerten Trägersubstanzen, wie etwa jenen, die in Patentanspruch 5 angegeben werden, vermengt wird.
  14. Ein Verfahren gemäß Patentanspruch 12, in welchem CR-2039 Dinatriumsalz als aktiver Bestandteil verwendet wird und Menthol als Geschmackstoff, Saccharin-Natrium als Süßstoff und Laktose oder Dextrose als wasserlösliche inerte Trägersubstanz.
EP97830417A 1997-08-08 1997-08-08 Neue Inhalationspräparate enthaltend CR 2039 (Andolast) Expired - Lifetime EP0896821B1 (de)

Priority Applications (9)

Application Number Priority Date Filing Date Title
PT97830417T PT896821E (pt) 1997-08-08 1997-08-08 Uma nova composicao farmaceutica para inalacao que contem cr 2039 (andolast)
ES97830417T ES2199336T3 (es) 1997-08-08 1997-08-08 Una composicion farmaceutica novedosa para inhalacion que contiene cr 2039 (andolast).
AT97830417T ATE241980T1 (de) 1997-08-08 1997-08-08 Neue inhalationspräparate enthaltend cr 2039 (andolast)
EP97830417A EP0896821B1 (de) 1997-08-08 1997-08-08 Neue Inhalationspräparate enthaltend CR 2039 (Andolast)
DE69722610T DE69722610T2 (de) 1997-08-08 1997-08-08 Neue Inhalationspräparate enthaltend CR 2039 (Andolast)
AU77327/98A AU735204B2 (en) 1997-08-08 1998-07-21 A novel pharmaceutical composition for inhalation containing CR 2039 (Andolast)
CA002244357A CA2244357C (en) 1997-08-08 1998-07-30 A novel pharmaceutical composition for inhalation containing cr 2039 (andolast)
US09/129,794 US5976576A (en) 1997-08-08 1998-08-06 Pharmaceutical composition for inhalation containing CR 2039 (Andolast)
JP22273898A JP4301598B2 (ja) 1997-08-08 1998-08-06 Ｃｒ２０３９を含有する吸入用医薬組成物

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP97830417A EP0896821B1 (de) 1997-08-08 1997-08-08 Neue Inhalationspräparate enthaltend CR 2039 (Andolast)

Publications (2)

Publication Number Publication Date
EP0896821A1 EP0896821A1 (de) 1999-02-17
EP0896821B1 true EP0896821B1 (de) 2003-06-04

Family

ID=8230753

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97830417A Expired - Lifetime EP0896821B1 (de) 1997-08-08 1997-08-08 Neue Inhalationspräparate enthaltend CR 2039 (Andolast)

Country Status (9)

Country Link
US (1) US5976576A (de)
EP (1) EP0896821B1 (de)
JP (1) JP4301598B2 (de)
AT (1) ATE241980T1 (de)
AU (1) AU735204B2 (de)
CA (1) CA2244357C (de)
DE (1) DE69722610T2 (de)
ES (1) ES2199336T3 (de)
PT (1) PT896821E (de)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0010709D0 (en) * 2000-05-03 2000-06-28 Vectura Ltd Powders for use a in dry powder inhaler
US7078423B2 (en) * 2002-07-18 2006-07-18 Inotek Pharmaceuticals Corporation 5-Aryltetrazole compounds, compositions thereof, and uses therefor
US7087631B2 (en) * 2002-07-18 2006-08-08 Inotek Pharmaceuticals Corporation Aryltetrazole compounds, and compositions thereof
US7037927B2 (en) * 2003-10-16 2006-05-02 Abbott Laboratories Amides that inhibit vanilloid receptor subtype 1 (VR1) receptor
WO2005123072A1 (en) * 2004-06-14 2005-12-29 Sepracor Inc. Methods and compositions for the treatment of pulmonary diseases
WO2005123071A1 (en) * 2004-06-14 2005-12-29 Sepracor Inc. Methods of using albuterol and calcium activated potassium channel openers
PT1634595E (pt) * 2004-08-19 2008-08-28 Rottapharm Spa Derivados de n-fenilbenzamida como fármacos para o tratamento doença pulmonar obstativa crónica (dpoc)
WO2007077164A1 (en) * 2006-01-06 2007-07-12 Boehringer Ingelheim International Gmbh New pharmaceutical compositions based on anticholinergics and andolast
DE602006007211D1 (de) * 2006-04-10 2009-07-23 Rottapharm Spa Neue kristalline und stabile Form von Andolast
PT2054057E (pt) * 2006-07-31 2011-05-05 Rottapharm Spa Combina??o de andolast/glucocortic?ides

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5192772A (en) * 1987-12-09 1993-03-09 Nippon Shinyaku Co. Ltd. Therapeutic agents
IT1232252B (it) * 1989-02-22 1992-01-28 Rotta Research Lab Derivati della n fenil benzamide ad attivita' antiulcera ed antiallerica e procedimento per la loro preparazione
US5780051A (en) * 1992-04-02 1998-07-14 Dynagen, Inc. Methods and articles of manufacture for nicotine cessation and monitoring nicotine use
CA2126685C (en) * 1992-10-26 2002-07-23 Bruno Gander Process for the production of microcapsules
US5453368A (en) * 1993-08-27 1995-09-26 Brown University Research Foundation Method of encapsulating biological substances in microspheres
US5855913A (en) * 1997-01-16 1999-01-05 Massachusetts Instite Of Technology Particles incorporating surfactants for pulmonary drug delivery
US5741168A (en) * 1996-06-21 1998-04-21 Chen; Ming-Sheng Toy glider as folded and assembled from two-dimensional elements

Also Published As

Publication number Publication date
ATE241980T1 (de) 2003-06-15
US5976576A (en) 1999-11-02
DE69722610D1 (de) 2003-07-10
DE69722610T2 (de) 2004-04-29
JP4301598B2 (ja) 2009-07-22
ES2199336T3 (es) 2004-02-16
EP0896821A1 (de) 1999-02-17
CA2244357A1 (en) 1999-02-08
AU735204B2 (en) 2001-07-05
PT896821E (pt) 2003-08-29
JPH11106339A (ja) 1999-04-20
CA2244357C (en) 2007-05-01
AU7732798A (en) 1999-02-18

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